Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

Carotid Artery Stenosis Clinical Trial

— RECAS  

Official title:

Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031610
• Other study ID #: ZJPPHEC2023O(290)
• Status: Recruiting
• Start date: June 10, 2023
• Est. completion date: May 2034

Study information

• Verified date: September 2023
• Source: Zhejiang Provincial People's Hospital
• Contact: Sheng Zhang, M.D.
• Phone: +8618758188313
• Email: zhangsheng[@]hmc.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 2034
• Est. primary completion date: December 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged = 40 years.

2. = 50% stenosis in unilateral carotid artery.

3. Sign informed consent.

Exclusion Criteria:

1. Previous history of major head trauma and any intracranial surgery

2. Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions

3. Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement.

4. Severe loss of vision, hearing, or communicative ability.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Cerebral Small Vessel Diseases
• Constriction, Pathologic

Intervention

Procedure:
• carotid artery stenting
Patients were monitored for at least 24 h after surgery, with control for hyperperfusion syndrome, dual antiplatelet therapy was continued for 4-6 weeks, and the postoperative patients have the final residual stenosis of less than 30%, thrombolysis in Myocardial Infarction (TIMI) grade 3, and no dissection or thrombosis. Any surgery-related complications were recorded.

Locations

Country	Name	City	State
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23. Erratum In: Lancet Neurol. 2023 Sep;22(9):e10. Lancet Neurol. 2023 Sep;22(9):e10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The development of total brain small vessel disease burden in MRI	Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.	baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary	Montreal Cognitive Assessment (MoCA) score	To assess changes in cognitive function of patients.	baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary	Mini-mental State Examination(MMSE) score	To assess changes in cognitive function of patients.	baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary	Blood flow density	Record blood flow density (%) of OCTA.	baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary	Vascular perfusion area	Record vascular perfusion area (mm^2) of OCTA.	baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary	Macular fovea retinal thickness	Record macular fovea retinal thickness (µm) of OCTA.	baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary	Retinal nerve fiber layer thickness	Record retinal nerve fiber layer thickness (µm) of OCTA.	baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary	Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP).	Change of the volume of delay time>3s in follow-up minus the volume at baseline.	baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Secondary	Stenosis percent	Restenosis can be identified by CTA/DSA evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention.	baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary	Number of Patients with cerebrovascular events, cardiovascular events or death	Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and cerebral hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.	baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.

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